Financial Performance - The net loss for the three months ended September 2024 was $10,592,000, compared to a net loss of $5,609,000 for the same period in 2023, indicating an increase in losses of 88.5%[20] - The net loss per common share for the three months ended September 2024 was $(2.85), slightly higher than $(2.82) for the same period in 2023[20] - Total operating expenses for the three months ended September 2024 were $7,135,000, compared to $5,947,000 for the same period in 2023, reflecting a 19.9% increase[20] - Interest income for the three months ended September 2024 was $102,000, a decrease from $324,000 for the same period in 2023, representing a decline of 68.5%[20] - Other income, net for the three months ended September 2024 was $9,000, down from $13,000 for the same period in 2023, a decrease of 30.8%[20] - The total loss from operations for the nine months ended September 2024 was $19,998,000, compared to $20,712,000 for the same period in 2023, showing a slight improvement of 3.4%[20] Research and Development - Research and development (R&D) expense increased to $4.9 million for Q3 2024, up from $3.3 million in Q3 2023, primarily due to clinical trial costs[9] - Research and development expenses for the three months ended September 2024 were $4,932,000, an increase from $3,280,000 for the same period in 2023, representing a 50.3% increase[20] - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for R/R AML treatment[4] - The company plans to present final data from the Phase 2 study of Annamycin for soft tissue sarcoma lung metastases in 2025[8] Clinical Trials - The company is on track to start dosing in the pivotal Phase 3 MIRACLE trial in Q1 2025, aimed at treating relapsed or refractory acute myeloid leukemia (R/R AML) with Annamycin and cytarabine[1] - The median durability of complete response composite (CRc) in the MB-106 trial has exceeded 8 months[2] - The MIRACLE trial will initially randomize approximately 75 to 90 subjects to receive high dose cytarabine combined with either placebo or Annamycin[6] - Expected milestones for the MIRACLE trial include first subject treated in Q1 2025 and interim efficacy data unblinded in 2H 2026[7] Financial Position - As of September 30, 2024, the company had cash and cash equivalents of $9.4 million, expected to fund operations into Q1 2025[10] - The company closed a financing of $5.5 million, with potential additional gross proceeds of up to $11.0 million upon the exercise of milestone-linked warrants[3] Administrative Expenses - General and administrative expense decreased to $2.2 million in Q3 2024 from $2.6 million in Q3 2023, reflecting a reduction in regulatory and legal fees[10]

- On track to start dosing in pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of R/R AML in Q1 2025- Median durability of CRc in MB-106 Annamycin+ Cytarabine AML clinical trial continues to climb - now past 8 months - Recent virtual AML KOL event underscores how Annamycin could significantly change the AML treatment landscape; Replay available here - Company to host conference call and web ...

Company Overview - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing drug candidates for hard-to-treat tumors and viruses [3] - The company's lead program, Annamycin, is a next-generation anthracycline aimed at avoiding multidrug resistance and reducing cardiotoxicity associated with current treatments [3] Financial Results Announcement - Moleculin will report its financial results for the quarter ended September 30, 2024, on November 8, 2024 [1] - A conference call and live audio webcast will be held on November 11, 2024, at 8:30 AM ET to discuss these results [1][2] Clinical Trials and Development - The company is initiating the MIRACLE Trial (MB108), a pivotal Phase 3 trial evaluating Annamycin in combination with cytarabine for relapsed or refractory acute myeloid leukemia (AML) [4] - Following a successful Phase 1B/2 study, Moleculin believes it has reduced the risks associated with the development pathway for Annamycin's approval [4] Additional Drug Development - Moleculin is also developing WP1066, an immune/transcription modulator targeting brain tumors and pancreatic cancers [5] - The company is working on a portfolio of antimetabolites, including WP1122, for potential treatment of pathogenic viruses and certain cancer indications [5]

Strong preclinical evidence of Annamycin's potential for treating pancreatic cancer presented at AACR expands collaborationHOUSTON, Nov. 4, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a late stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced the appointment of Daniel D. Von Hoff, M.D., F.A.C.P., FASCO, FAACR to its Annamycin Scientific Advisory Board.Walter Klemp, Chairman and Chief E ...

HOUSTON, Oct. 4, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-totreat tumors and viruses, today announced its participation at two upcoming investor conferences. Details of the upcoming presentations are as follows: 3rd Annual ROTH Healthcare Opportunities Conference Format: Panel - Innovative Therapies for Liquid Tumors The panel will cover the drugs in development by ...

Data recently presented at the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer Treatment with Annamycin results in statistically significant inhibition of tumor growth and extension of survival in orthotopic lung cancer models Annamycin continues to be 100% non-cardiotoxic HOUSTON, Sept. 23, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug can ...

Wally Klemp, CEO of Moleculin, discusses the Company's recent update on the Phase 2 clinical trial of STAT3 inhibitor in combination with radiation for the treatment of glioblastoma Watch the "What This Means" video here HOUSTON, Sept. 16, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company), a Phase 3 clinical-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced that Walter Klemp, Chairman an ...

– Investigator-initiated Phase 2 study is being conducted at Northwestern University in cooperation with Moleculin – Funding for study provided by NIH and BrainUp® – Trial combines WP1066 and radiation, which demonstrated both significant therapeutic response and immune memory in glioblastoma animal models HOUSTON, Sept. 9, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company), a Phase 3 clinical-stage pharmaceutical company with a broad portfolio of drug candidates targ ...

Table of Contents As filed with the Securities and Exchange Commission on August 15, 2024. Registration No. 333-280951 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 3 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Moleculin Biotech, Inc. (Exact name of registrant as specified in its charter) | Delaware | 2834 | 47-4671997 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Industrial | (I.R.S. Employer | | incorporation or ...

As filed with the Securities and Exchange Commission on August 14, 2024. | Delaware | 2834 | 47-4671997 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Industrial | (I.R.S. Employer | | incorporation or organization) | Classification Code Number) | Identification Number) | | | 5300 Memorial Drive, Suite 950 | | | | Houston, Texas 77007 | | | | (713) 300-5160 | | Registration No. 333-280951 (Address, including zip code, and telephone number, including area code, of registrant's pr ...